CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 304 enrolled
Drug / intervention
EUS-FNA/EBUS-TBNA + BAL +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00872612
NCT00872612Phase 3Completed
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Endosonography (EUS and EBUS) vs Conventional Bronchoscopy for the Diagnosis of Sarcoidosis: a Randomized Trial

Leiden University Medical Center·interventional·Posted Mar 31, 2009·Updated Dec 7, 2015

In Brief

A Phase 3 clinical trial evaluating EUS-FNA/EBUS-TBNA + BAL and EBB + TBLB + BAL for Sarcoidosis. Completed, enrolled 304 participants across 15 sites in 6 countries.

Detailed Summary

This randomized study investigates two different diagnostic strategies for patients with suspected pulmonary sarcoidosis stage I/II. The objective is to assess the role of endosonography (EBUS/ EUS - FNA) in demonstrating non-caseating granulomas in comparison with conventional bronchoscopy (TBLB + EBB). Also the researchers investigate the additional value of BAL, in relation to endosonography and conventional bronchoscopy (TBLB + EBB), in diagnosing sarcoidosis. Thirdly the researchers aim to assess the rate of complications in both the endosonography and conventional bronchoscopic workup.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcoidosis
CountriesBelgium, Denmark, Germany, Netherlands, Poland, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 31, 2009
Enrollment StartMar 1, 2009
Primary CompletionNov 1, 2011
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 17.3 years ago

Interventions

EUS-FNA/EBUS-TBNA + BALprocedure

EUS-FNA = Endoscopic Ultrasound guided fine needle aspiration of mediastinal lymph nodes. EBUS-TBNA = Endobronchial Ultrasound guided transbronchial needle aspiration of mediastinal and hilar lymph nodes. BAL = bronchoalveolar lavage

EBB + TBLB + BALprocedure

EBB = Endobronchial biopsy TBLB = Transbronchial biopsy BAL = Bronchoalveolar lavage